Siemens Careers

Senior Quality Engineer (Medical Device) - Manufacturing

East Walpole, Massachusetts
Quality Management

English (US)

Job Description

Division: Siemens Healthineers
Business Unit: Laboratory Diagnostics
Requisition Number: 222357
Primary Location: United States-Massachusetts-East Walpole
Assignment Category: Full-time regular
Experience Level: Senior level
Education Required Level: Bachelor's Degree
Travel Required: 10%

Division Description:

Division Description

Siemens is a global technology powerhouse that has stood for engineering excellence, innovation, quality, reliability and internationality for more than 165 years. As a global technology company, Siemens is rigorously leveraging the advantages that this setup provides. To tap business opportunities in both new and established markets, the Company is organized in nine Divisions: Power and Gas, Wind Power and Renewables, Energy Management, Building Technologies, Mobility, Digital Factory, Process Industries and Drives, Healthineers and Financial Services.

With 45,000 employees Siemens Healthineers is one of the world’s largest suppliers of technology to the healthcare industry and a leader in medical imaging, laboratory diagnostics and healthcare IT. All supported by a comprehensive portfolio of clinical consulting, training, and services available across the globe and tailored to customers’ needs. So that more people can have a life that is longer, richer, and more filled with happiness.

Job Description:

Position Overview
This is a mid-level Quality Engineering position that requires an individual with process validation and facility qualification knowledge/experience in a regulated environment, e.g., IVDD, Medical Device, Pharmaceutical, Biotech, etc.  The individual in this role will be responsible for supporting various quality engineering activities as part of the China expansion project.  This position is based in Walpole, MA and reports into the China expansion Sr. Quality Manager, also based in Walpole
In this role the individual will be responsible for leading or participation on individual validation and qualification activities for process, equipment, facilities and utilities of an IVD manufacturing facility to be built in China.  Will work closely with the other project core team leads/functions, e.g., Manufacturing, Technical Operations, Engineering and Quality Assurance, to ensure that processes are appropriately qualified/validated in a timely manner.    In addition, the individual will provide supports on other quality engineering activities such as DHF gap closure, Product Technical Requirement (PTR) development and testing, Packaging development and testing, Risk Management gap closure as needed.
Specific responsibilities include but not limited to:
  • Support in development of Site Validation Master Plan.
  • Create and develop individual qualification and validation protocol and report
  • Work with Engineering on specific equipment, facility and utility validation plans and reports.
  • Supports on other quality engineering activities such as DHF  gap closure, Product Technical Requirement (PTR) development and testing,  Packaging development and testing, Risk Management gap closure as needed
  • Ensure that all qualification/validation plans, protocols and reports are complete, accurate and compliant with applicable requirements, including those of the China FDA.
  • May require some travel to China.
Required Knowledge/Skills, Education, and Experience
Experience:        A minimum of 5 years in the medical device, biotechnology or pharmaceutical industry, with a Quality Engineer or Validation Engineer role. 
Education:          A minimum of a 4 year degree is required.
  • Knowledge of CFR 21 Part 820 (QSR), ISO 13485, CMDCAS, MDD 93/42, PAL, and other domestic and international regulations that may apply
  • Experience in the application of production and process controls including process validation, test method validation, process control plans, statistical process control, risk management and statistical tools.
  • Experience in Design Control and risk management
  • Excellent verbal and written communication skills.
  • Must be able to work collaboratively with other project team members.
Preferred Knowledge/Skills, Education, and Experience
  • Prior experience with facility start-up/qualification projects.
  • A quality engineering certification from the American Society for Quality other qualifying organization is required.  Examples include the CQE, CRE, etc.
  • Fluent in Chinese is a plus  
  • Knowledge of CFDA IVD GMP requirements
  • Prior experience in an IVDD manufacturing environment

Equal Employment Opportunity Statement
Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, protected veteran or military status, and other categories protected by federal, state or local law.

EEO is the Law
Applicants and employees are protected under Federal law from discrimination. To learn more, Click here.

Pay Transparency Non-Discrimination Provision
Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here.

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